Abstract
In low-income countries, including the east African region, a third of neonatal deaths are due to infections. A substantial proportion of these have been attributed to sepsis, which can result from umbilical cord infections. Evidence from Asia suggests that chlorhexidine application to the neonatal umbilical cord reduces mortality, but no data from Africa are available. We aimed to assess the effect of umbilical cord cleansing with 4% chlorhexidine solution on neonatal mortality and omphalitis in rural settings of sub-Saharan Africa. We did a community-based randomised controlled trial on Pemba Island, Zanzibar, Tanzania. All eligible babies (aged 1 h to 48 h, without congenital malformations) from hospital-based and community-based deliveries on Pemba Island were enrolled. Participants were randomly assigned to either 4% free chlorhexidine for cord care or to dry cord care using a computer-generated random sequence. For babies allocated to the chlorhexidine group, mothers or caretakers were advised to apply the solution to the cord every day until 3 days after the cord had dropped off. Cord stumps were examined for redness, pus, swelling, and foul odour on day 0, 1, 4, 10, and 28. The primary outcome for this study was mortality until day 28 on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, number NCT01528852. Between May 19, 2011, and Aug 31, 2014, 36 911 newborn babies were enrolled into the chlorhexidine (n=18 015) and dry cord care study (n=18 896) groups. 17 468 (96·9%) of 18 015 neonates in the chlorhexidine group were available for complete follow-up (28 days) compared with 18 384 (97·3%) of 18 896 neonates in the dry cord care group. Mortality rate in the chlorhexidine group (10·5 deaths per 1000 livebirths) was not significantly lower than that in the dry cord care group (11·7 per 1000 livebirths; relative risk 0·90, 0·74-1·09; p=0·27). Our findings do not support the use of chlorhexidine for reduction of neonatal mortality in this east African setting, which might not justify a change in the WHO policy. To inform global policy, a detailed meta-analysis and pooled analysis needs to be undertaken using data from both African and Asian settings. Bill & Melinda Gates Foundation.
Highlights
Asia and sub-Saharan Africa have the highest neonatal mortality rates in the world,[1] with about 50% of neonatal deaths occurring on the first day of life.[2]
The worldwide neonatal mortality rate fell from 36 deaths per 1000 livebirths in 1990 to 19 in 2015.1 Infections are estimated to be responsible for 31·5% of these deaths between 2000 and 2015.3,4 Neonatal sepsis affects six to 21 babies per 1000 livebirths, with a case-fatality rate of 27–56% leading to more than 336 357 deaths per year.[3]
Percutaneous invasion of pathogens from umbilical cord infections has been postulated as a major cause of neonatal sepsis.[5,6]
Summary
Asia and sub-Saharan Africa have the highest neonatal mortality rates in the world (about 29 deaths per 1000 livebirths),[1] with about 50% of neonatal deaths occurring on the first day of life.[2]. Unsanitary conditions in delivery and care of newborn babies might contribute to the high rate of omphalitis and serious systemic infection.[7] Approaches such as hygiene promotion (including handwashing related to delivery and neonatal care), intrapartum vaginal and neonate skin cleansing with antiseptics such as chlorhexidine, and use of clean birth kits have been implemented to reduce the risk of neonatal infections.[8,9,10] Three clinical trials[7,8,11] have provided evidence about the effectiveness of chlorhexidine application to the neonatal umbilical cord in Asia, but no data from Africa exists. Current WHO guidelines[12] suggest application of chlorhexidine to the umbilical stump during the first week of life for babies born at home in settings with high neonatal mortality (≥30 neonatal deaths per 1000 livebirths) and to use dry cord care for newborn babies in settings with lower (
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